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Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SU011248

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate glad.
Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines.
Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
Patients must have elected to and are a candidate to undergo a radical prostatectomy.
Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group.
Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis.
Performance status: ECOG < 2.
Life expectancy of at least 5 years.
Absolute granulocyte count > 1,500/mm3.
Platelet count > 100,000.
Hemoglobin > 9.0 g/dL.
Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy.
Creatinine < 1.5 ULN.

Exclusion Criteria:

Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma.
Surgery within four weeks of study entry.
Evidence of regional and/or distant metastases.
Use of an investigational drug within 30 days prior to study entry.
NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
Any of the following thing the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
Prolonged QTc interval on baseline EKG.
Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).
Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
Known active infection.

Sites / Locations

University of California, Los Angeles, Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

5 Subjects will receive 37.5 mg/d of the study drug for 1 week.

5 Subjects will receive 50.0 mg/d of the study drug for 1 week.

5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.

Outcomes

Primary Outcome Measures

To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.

To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy.

Secondary Outcome Measures

To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels.

Full Information

NCT ID

NCT00790595

First Posted

November 12, 2008

Last Updated

July 27, 2012

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00790595

Brief Title

Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Official Title

Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself. New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

5 Subjects will receive 37.5 mg/d of the study drug for 1 week.

Arm Title

Group B

Arm Type

Experimental

Arm Description

5 Subjects will receive 50.0 mg/d of the study drug for 1 week.

Arm Title

Group C

Arm Type

Experimental

Arm Description

5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.

Arm Title

Group D

Arm Type

Experimental

Arm Description

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

Arm Title

Group E

Arm Type

Experimental

Arm Description

5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

SU011248

Intervention Description

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

SU011248

Intervention Description

5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

SU011248

Intervention Description

5 Subjects will receive 50.0 mg/d of the study drug for 1 week.

Intervention Type

Drug

Intervention Name(s)

SU011248

Intervention Description

5 Subjects will receive 37.5 mg/d of the study drug for 1 week.

Intervention Type

Drug

Intervention Name(s)

SU011248

Intervention Description

5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.

Primary Outcome Measure Information:

Title

To evaluate the effects of SU011248 by histological examination of prostate tumors following radical prostatectomy.

Time Frame

24 months

Title

To determine maximum tolerable dose of SU011248 when administered with prostate cancer prior to radical prostatectomy.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

To evaluate the effects of SUO11248 on tumoral phospho VEGF/PDGF, receptor TK pathways, microvessel density, antiangiogenic activities and serum PSA levels.

Time Frame

4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate glad. Informed of, willing, and able to comply with, the requirements of the investigational study and have signed a written informed consent in accordance with institutional regulatory guidelines. Subjects defined as being at high risk for disease relapse based on the following criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b. Patients must have elected to and are a candidate to undergo a radical prostatectomy. Males greater than 18 years of age and less than or equal to 75 years of age (physiologic) any racial/ethnic group. Free of significant abnormal findings as determined by screening history, physical exam, vital signs (blood pressure, heart rate, respiration rate, and temperature), and urinalysis. Performance status: ECOG < 2. Life expectancy of at least 5 years. Absolute granulocyte count > 1,500/mm3. Platelet count > 100,000. Hemoglobin > 9.0 g/dL. Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST values within normal range. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy. Creatinine < 1.5 ULN. Exclusion Criteria: Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL. Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy, biological response modifiers, or systematic chemotherapy to treat prostatic carcinoma. Surgery within four weeks of study entry. Evidence of regional and/or distant metastases. Use of an investigational drug within 30 days prior to study entry. NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment. Any of the following thing the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2. Prolonged QTc interval on baseline EKG. Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy). Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study Known active infection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arie Belldegrun, M.D.

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles, Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

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Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

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